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ISO 14971:2007Withdrawn

Medical devices — Application of risk management to medical devices

Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux

This edition has been replaced by ISO 14971:2019.

Abstract / scope

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Life cycle

Replaces

ISO 14971:2000WithdrawnMedical devices — Application of risk management to medical devicesInternational Standard · Published 30 Nov 2000 · ISO/TC 210ISO 14971:2000/Amd 1:2003WithdrawnMedical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirementsInternational Standard · Published 19 Feb 2003 · ISO/TC 210

Replaced by

ISO 14971:2019PublishedMedical devices — Application of risk management to medical devicesInternational Standard · Published 10 Dec 2019 · ISO/TC 210